NCT05084079

Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in SIIT

The Impact of Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in Short-term Intensive Insulin Therapy(SIIT)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes mellitus(T2DM) patients, in order to investigate the rational of formula based initiation regimen.

Detailed description

Diabetes has become one of the major chronic non-communicable diseases. Its prevalence was rising in these years. Short-term intensive insulin therapy can improve the β-cell function and nearly half of the patients can live with long-term glycemic remission. It has therefore become the recommended treatment for the newly diagnosis T2DM patients with high blood glucose. However, due to the glycemic goal for intensive therapy is strict, it's important to find out a suitable initial insulin regimen for continuous subcutaneous insulin infusion(CSII) with which patients can achieve euglycemia safely, stably and rapidly. In previous study, the investigators found out that the total daily insulin dose at the first day when euglycemia was achieved（TDD-1） was associated with weight, waist circumference, triglycerides and fasting blood glucose levels. According to this, the investigators figured out a formula for estimation of insulin dose for the short-term intensive insulin therapy in patients with newly diagnosed T2DM. However, its feasibility needs to be further verified. Therefore, the investigators conducted this prospective randomized controlled study to compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes patients, in order to investigate the rational of formula based initiation regimen.

Conditions

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Metabolism Disorders
• Metabolic Disease
• Endocrine System Diseases

Interventions

Type	Name	Description
DRUG	CSII with formula-based initial insulin regimen	Initial total daily insulin dose(TDD) for CSII was calculated with a formula :（estimate TDD-1(eTDD-1) = 0.35× body weight (kg) + 2.05× FPG (mmol/L) + 4.24×triglyceride(mmol/L) + 0.55× waist circumference (cm) - 49.1）, 42% of which was assigned as total basal dose and 58% as total premeal dose, with the pre-meal doses divided into 30:35:35 for breakfast, lunch and dinner.
DRUG	CSII with weight-based initial insulin regimen	TDD for CSII was started with 0.5 IU/kg, 50% of which was assigned as total basal dose and 50% as total premeal dose, and the total pre-meal dose was divided equally before each meal.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2021-10-19
• Last updated: 2021-10-19

Locations

1 site across 1 country: China